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    Process Engineer III - San Diego, United States - Abzena

    Abzena
    Abzena San Diego, United States

    5 days ago

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    Description


    With extensive experience in developing biologics and bioconjugates, we offer a seamless service delivered by fully integrated teams, from early discovery to commercial manufacturing.

    Forward-thinking and committed, we find the best solution and use the right technologies to design, develop and manufacture your products to ensure we get vital medicines to patients quickly and safely.

    We are dedicated to quality excellence.

    We are driven to get better treatments to market, efficiently and responsibly by reducing timelines and delivering the highest quality products and services.

    We are Abzena.

    More than a CDMO, we are a responsible and dedicated partner that takes care of your products from concept to patient.

    Responsible for supporting the Engineering Department as part of a rapidly expanding GMP Contract Manufacturing Organization. Facilities Process Engineers have Engineering responsibility for the entire area they serve. They are expected to be the Subject Matter Expert (SME) in their respective areas. Engineering is responsible for ensuring the site is well maintained and ready for use.


    This includes overseeing/coordinating the following:
    Process Engineer (Upstream) - is responsible for the planning, operation and ready for use of all upstream equipment operations.

    This position is the SME on the upstream process from an equipment standpoint and includes input on tech transfer, commissioning, manufacturing, and maintenance of all upstream equipment at the site.

    Process Engineer (Downstream) - is responsible for the planning, operation and ready for use of all downstream equipment operations.

    This position is the SME on the upstream process from an equipment standpoint and includes input on tech transfer, commissioning, manufacturing, and maintenance of all downstream equipment at the site.

    Process Engineer (Utilities) - is responsible for the planning, operation and ready for use of all utility operations.

    This position is the SME on utilities from an equipment standpoint and includes input on tech transfer, commissioning, manufacturing, and maintenance of all utility systems at the site.

    including the building management system (BMS).Responsible for all Engineering operations in the specific area of expertise.

    This includes working on CAPEX projects, providing technical assistance to maintenance/metrology, development/maintenance/continuous improvement of job plan templets, reliability of systems, automation, validation, etc.

    Responsibilities include the ability to produce high-quality documentation that contributes to the overall success of the site.

    Process Engineers are responsible for completion of Change Controls, Deviations, CAPAs, Risk Analysis (FMEAs and Criticality Assessments), SOPs and other documentation.

    Ensures Engineering Department compliance measures are maintained, all documentation meets regulatory requirements, and is completed according to determined timelines.

    Process Engineers may also lead or act as a member for special projects as determined by Engineering Management in support of continued improvement of site and/or department goals and initiatives.

    ResponsibilitiesSME for the areaProvide technical assistance to area personnel to solve complex problemsExercises judgement in developing practices, techniques, and evaluation criteria for obtaining results.

    Technical Writing (SOPs, Job Plans, FMEAs, Criticality Assessments, etc.)System Reliability Management Continuous Improvement Projects.
    Deviation/CAPA Management.
    Other duties consistent with knowledge, skills and ability as assignedQualificationsBachelor's Degree required.
    Demonstrated ability to work in a team environment and strong communication skills within all levels of an organization.

    Subject Matter Expert (SME) in 1 key area of responsibility (Upstream/Downstream, Utilities) and ability to lead and train on day-to-day process, along with day-to-day knowledge in one of the other areas.

    Demonstrated ability to develop technical writing documents such as Change Controls, Deviations/CAPAs, SOPs, Job Plans, FMEAs, Criticality Assessments, etc.

    Demonstrated administrator knowledge of computer systems in the specific area of expertise for example BMS for Utilities, CMMS for GMP Support, specific equipment software for Upstream/Downstream, etc.).Demonstrated knowledge of maintenance and/or metrology activities (preventative/corrective maintenance, calibration).

    Ability to support internal and external audits.
    Prior experience in reliability and continuous improvement projects a plus$100,000 - $150,000 a year


    FLSA:
    ExemptAbzena is an equal opportunity employer that is committed to diversity and inclusion in the workplace.

    We prohibit discrimination and harassment of any kind based on race, color, sex, religion, sexual orientation, national origin, disability, genetic information, pregnancy, or any other protected characteristic as outlined by federal, state, or local laws.

    This policy applies to all employment practices within our organization, including hiring, recruiting, promotion, termination, layoff, recall, leave of absence, compensation, benefits, and training
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